EMA: Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use.

This guideline addresses issues relating to the unwanted immunogenicity of monoclonal antibodies (mAbs) intended for clinical use. These include factors impacting on immunogenicity of mAbs, the clinical consequences of immunogenicity, assay related problems, assessing neutralizing antibodies induced by mAbs and consideration of a risk-based approach for the evaluation of immunogenicity of mAbs.